NCT01654640 is a Phase 4 clinical trial of Metformin in Schizophrenia, sponsored by Seoul National University Hospital.

Who is sponsoring NCT01654640?

NCT01654640 is sponsored by Seoul National University Hospital.

What drugs are being tested in NCT01654640?

Interventions in NCT01654640: Metformin, Placebo (for metformin).

What condition does NCT01654640 study?

NCT01654640 studies Schizophrenia.

Is NCT01654640 still recruiting?

NCT01654640 is currently terminated. Last updated 5 September 2018.

Last reviewed 2018-09-05 · How we verify

NCT01654640

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 4 Study of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine

Terminated Phase 4 Last updated 5 September 2018

What this trial tests

Phase 4 trial testing Metformin in Schizophrenia in 15 participants. Terminated before completion.

Timeline

1 September 2012

Primary endpoint
1 April 2015

1 April 2015

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	15
Start date	1 September 2012
Primary completion	1 April 2015
Estimated completion	1 April 2015
Sites	1 location across South Korea

Drugs / interventions tested

Metformin (metformin) — full drug profile →
Placebo (for metformin) — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →

Sponsor

Seoul National University Hospital

Who can join

Adults 18 to 65, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

change of weight
Time frame: baseline, 12 weeks, 24 weeks
change of weight after 12-week, 24-week. calculation; (weight of 12-week - weight of baseline)/baseline weight (weight of 24-week - weight of baseline)/baseline weight

Sponsor's own description

The purpose of this study is the evaluation of effect of metformin on obesity and metabolic disturbance in patients taking clozapine.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The potential effect of metformin on cognitive and other symptom dimensions in patients with schizophrenia and antipsychotic-induced weight gain: a systematic review, meta-analysis, and meta-regression.
Battini V, Cirnigliaro G, Leuzzi R, Rissotto E, et al · · 2023 · cited 17× · PMID 37502816 · DOI 10.3389/fpsyt.2023.1215807

Verify or expand the search:

Other trials of Metformin

Trials testing the same drug.

NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
NCT07520110 — Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07007221 — Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV · Phase 2 · not yet recruiting
NCT07585396 — Inositol in Letrozol Resistant PCOS Women · Phase 2, PHASE3 · not yet recruiting
NCT07226453 — Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma · Phase 2 · not yet recruiting

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting

Other Seoul National University Hospital trials

Trials by the same sponsor.

NCT07262944 — EOI Block in Otoplasty With Rib Cartilage Graft · NA · recruiting
NCT07464210 — Nemtabrutinib, Bortezomib, and Rituximab for WM · Phase 2 · not yet recruiting
NCT07550803 — Effect of Intraoperative Dexamethasone on Early Postoperative Sleep Quality in Patients Undergoing Nasal Surgery · NA · not yet recruiting
NCT07522138 — Home-based Self-exercise in Patients With Parkinson's Disease: A Feasibility Study · NA · not yet recruiting
NCT07476651 — Scout Dose of Resin Microspheres · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01654640 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Seoul National University Hospital
Last refreshed: 5 September 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01654640.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing